Female Urethral Catheterization - Instillation of the Lubricating Gel Into the Urethra or Pouring it on the Catheter's Tip?
NCT ID: NCT01985516
Last Updated: 2013-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
96 participants
INTERVENTIONAL
2013-10-31
2014-09-30
Brief Summary
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Urethral lubrication can be performed in two different techniques: instillation of the gel directly into the urethra or pouring the gel on the catheter's tip. In this study, we will evaluate the pain level during female urethral catheterization in each technique.
Our hypothesis is that the level of pain will be much less if the lubrication agent will be instilled directely to the urethra.
Detailed Description
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Women aged 18 years and older who will be referred for multichannel Urodynamic study in order to evaluate lower urinary tract symptomswill be included.
Patients will be randomized to 2 groups: (1) 5mL of 2% lidocaine gel instilled directly into the urethra 5 minutes before catheterization; (2), 5mL of 2% lidocaine gel poured on the distal part of the catheter. The randomization technique will be employed by a computerized random number generator.
A 12F Nelaton urethral catheter will be introduced in order to measure post-void residual volumes. Subsequently, multichannel Urodynamic testing (Duet Encompass System - Mediwatch Group Plc) will be performed using a dual lumen 6F urethral and 9F rectal catheters. Filling will be carried out using room temperature saline at a filling rate of 50 ml/min.
Patients will be requested to fill out a 0 (no pain) to 10 (worst imaginable pain) visual analog pain scale (VAS) in different time points: prior to gel instillation (baseline), immediately after gel instillation (only in group 1), immediately after the introduction of the Nelaton catheter, 5 and 30 minutes after the catheter will be taken out.
Time frame of the study: 30 minutes before the test and 1 hour after the test. Since the study evaluates pain during the procedure the time frame of the study and assessment is very short. longer follow-up is not needed.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Instillation into the urethra
5mL of 2% lidocaine gel will be instilled directly into the urethra 5 minutes before catheterization
Instillation into the urethra
5mL of 2% lidocaine gel will be instilled directly into the urethra 5 minutes before catheterization
Pouring the gel on the tip of the catheter
5mL of 2% lidocaine gel will be poured on the distal part of the catheter (from the distal tip to 10 cm proximally)
pouring the gel on the catheter's tip
5mL of 2% lidocaine gel will be poured on the distal part of the catheter (from the distal tip to 10 cm proximally).
Interventions
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Instillation into the urethra
5mL of 2% lidocaine gel will be instilled directly into the urethra 5 minutes before catheterization
pouring the gel on the catheter's tip
5mL of 2% lidocaine gel will be poured on the distal part of the catheter (from the distal tip to 10 cm proximally).
Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
\-
18 Years
FEMALE
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Assaf Harofeh MC
Dr Kobi Stav
Principal Investigators
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Kobi Stav, MD
Role: PRINCIPAL_INVESTIGATOR
Assaf Harofe Medical Center
Locations
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Assaf Harofe Medical Center
Beer Yaakov, Zeriffin, Israel
Countries
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Central Contacts
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Facility Contacts
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Kobi Stav, MD
Role: primary
Other Identifiers
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132/13
Identifier Type: -
Identifier Source: org_study_id